John Burklow:Good morning
everyone and welcome to the NIH Press Briefing on the proposed changes to the
financial conflict of interest regulations. We'll be hearing from NIH Director
Dr. Francis Collins and we'll follow up with a Q&A.

We
also have Dr. Sally Rockey, Deputy Director for Extramural Research at NIH, on
the line for other questions as well. So I'll turn it over now to Dr. Collins.

Francis Collins:I'm glad to be
able to join this call to tell you about the notice of proposed rulemaking
about financial conflicts of interest which will be posted in the Federal
Register, tomorrow, May 21.

This
so-called NPRM is entitled Responsibility of Applicants for Promoting
Objectivity in Research for which Public Health Service Funding is Sought and
Responsible Prospective Contractors. This proposes changes to existing
regulations that have been in place since 1995. And this NPRM will be open now
for public comment for 60 days.

I want
to put this in context for a moment. Clearly the way in which science is moving
forward in order to be successful and particularly so when it comes to the
development of new diagnostic and therapeutic advances partnerships between
NIH-funded researchers and industry are essential; they have been and they will
be.

At the
same time we need to be clear that in order to preserve the public trust in the
objectivity of biomedical and behavioral research all research has to be conducted
without bias and with the highest scientific and ethical standards.

This
notice of proposed rulemaking will be a substantial change in the way in which
NIH seeks to oversee potential financial conflicts of interest and will make
some differences for investigators who are in universities and institutes and
in small businesses who are being supported by NIH funds in terms of the
disclosure requirements that will now be put in front of them.

And
again I'm saying this - this is what the NPRM says and we'll see what the
public comments have to say. This will not be finalized until later this year
after receiving those comments.

A few
examples of the changes the de minimis threshold for reporting will be reduced
from $10,000 to $5000. The responsibility for deciding about whether a
particular relationship is a potential financial conflict of interest will now
rest upon the institution as opposed upon the investigator so that the
institution is therefore required to set up a process to review such potential
conflicts of interest to identify those that may need an intervention and to
report to NIH its actions in that regard.

This
will now include SBIR and STTR, Phase 1 applications which were previously not
included. It will exclude, however, income from seminars, lectures or teaching
or service on advisory or review panels for government agencies or institutions
of higher education.

And
there will be a disclosure component to this. So where institutions will now be
required to develop a publicly accessible Website, that will display
significant financial interests of their faculty and other institutional
members in order for the public to have a clear pathway towards identifying
what kinds of arrangements have been made so that there is transparency to the
process.

We
believe that in the past the process that has been followed for the most part
has been successful. And again I don't mean to imply in any of the things that
I'm saying that I think there has been a widespread problem in terms of financial
conflicts of interest.

But
there clearly have been a few examples uncovered in the last few years where
investigators were involved in financial conflicts that could be at least
perceived as coloring their judgment and perhaps affecting publications that
they were involved in.

As the
NIH Director I think I can say with great sincerity that the public trust in
what we do is just essential, and we cannot afford to take any chances with the
integrity of the research process. And therefore even though these proposed new
rules may provide some burden to the investigator and to the institutions in
terms of additional reporting requirements we believe that it is essential to
tighten up this situation in order to be sure that we are obtaining and
maintaining the public trust in the integrity of the scientific enterprise.

I
think that’s about all that I would like to say by way of introduction. Sally
Rockey who is on the telephone who is the Acting Deputy Director for Extramural
Research has been deeply engaged in this process which began well before I
arrived last August and can handle any of the detailed questions that you might
have. But I would now like to see whether there are questions from people on
the phone about today’s announcement.

Coordinator:Thank you. If
you would like to ask a question please unmute your phone, press star 1 and
record your name when prompted. To withdraw your question at any time you may
press star 2. Once again if you would like to ask a question please press star
1 and record your name when prompted. One moment...

John Burklow:And also please
identify yourself and your outlet as well. This is John, thanks.

Coordinator:One moment
please for the first question. The first question comes from Meredith with
Nature.

Meredith Wadman:Hi, this is
Meredith Wadman with Nature. I see that the de minimis threshold is lowered to
$5000. Do you include any requirements for increments in that reporting? In
other words is it $5000-$20,000 and then $20,000-$50,000 and - because at some
point if it’s like over $100,000 and someone’s collecting $2 million it just
becomes very uninformative.

Does
NIH stipulate the categories of increments that must be reported?

Sally Rockey:Meredith, hi,
this is Sally. Yes, we - for the information that is being reported to NIH we
have ranges as well as the information that’s going to be publicly posted. So
the ranges for the information that is coming to NIH include the value of the
financial interest and our ranges are $0-$4999, $5000-$9999, $10,000-$19,999
and then up to $100,000 by $20,000 increments and above $100,000 by $50,000
increments.

For
the case of the public disclosure our increments are - hold on just one second
I'm sorry, the public disclosure - oh it’s less than $20,000, less than $50,000,
less than $100,000 and then up to $250,000 and then above $250,000.

Now
remember that the public disclosure is - they will disclose those significant financial interests that the institution has deemed constitutes
financial conflicts of interest. So they - in the proposal they’re not required
to disclose all significant financial interests but only those that are deemed
as a financial conflict - related to those that are deemed as a financial
conflict of interest.

I will
also point out that for the public disclosure this applies to PIs and key
personnel.

Meredith Wadman:Thanks for
that. And there’s - above $250k the public just takes a guess at how much that
might be?

Sally Rockey:At above
$250,000, yes.

Meredith Wadman:Right. Okay,
thank you.

John Burklow:Thanks Meredith.
Next question please .

Coordinator:Theresa Defino
from Report on Research Compliance.

Theresa Defino:Hey, thank you.
Two quick questions and without having the rule in front of us I think we’re all
a little handicapped in being able to ask more detailed questions...

John Burklow:Yes. It went up -
this is John Burklow. It’s up for public viewing as of 8:45 this morning...

Theresa Defino:Oh okay.

John Burklow:...on
the Federal Register Website and tomorrow it is published but they always put
it up one day ahead.

Theresa Defino:Okay I guess I
didn't check late enough in the morning. What are the penalties for
noncompliance? And I'm guessing that institutions are going to object to a lot
of the reporting requirements unless they can build compliance costs into their
grants.

Sally Rockey:So again this
is Sally. We have a variety of corrective enforcement actions in the cases
where an awardee fails to comply with the terms and conditions which include
how they manage their - the financial interest of their staff members including
can be things such as an imposition of special award conditions. We can suspend
funding until the matter is resolved.

We can
withhold support. For example we could determine not to make any non-competing
continuations until the problem is resolved. Or in fact we can terminate
awards.

Theresa Defino:Thank you. And
my other question was would you consider the compliance costs being built into
any grant request?

Sally Rockey:Yeah, it’s in
the indirect cost portion of the grant.

John Burklow:Okay thanks very
much Theresa. Next question please.

Coordinator:Our next
question comes from (Jenny Bowman). And please state your organization.

(Jeanie Bowman):Hi, yes, this is
(Jeanie Bowman) from B&A. I know that there was some discussion about the -
changing the de minimis from everything from eliminating it all together to
making it as low as $100. I was wondering how you ended up with $5000?

Sally Rockey:I'll take that
question. This is Sally again. Yes, you’re right, we
considered many alternatives from keeping the de minimis where it was to lowing
it to where we proposed at $5000. And we also considered alternatives to
reducing it even further all the way down to zero.

So
what we did was we analyzed whether or not this - a significantly lower
threshold at like the zero, $100 range, would be appropriate but we were
extraordinarily concerned about the administrative costs associated with
disclosures and all the review that would have to go on with those disclosures
of all but a negligible financial interest.

And we
wanted to - we determined that that probably would outweigh the intended
benefit of the regulations and promoting objectivity. Now we also heard quite a
bit from the public when we did the ANPRM and many of the suggestions for
lowering it ranged in the $5000 range.

Also
if you - in the notice of proposed rulemaking there’s a preamble and that
preamble sets up our rational very nicely. And you can see our discussion of
our reasoning for the alternatives and why we either accepted or rejected some
of these alternatives at this point.

(Jeanie Bowman):Great, thank you.

John Burklow:All right,
thanks (Jeanie). Next question please.

Sally Rockey:And I would -
I'd just like to say again remember we'd very much appreciate comments from
whatever source. We really are looking towards these comments in the
development of the final rule.

John Burklow:Okay. Next question.

Coordinator:Our next
question comes from Paul Basken of Chronicle of Higher Education.

Paul Basken:Hi, thank you.
On the exclusions it says exclusions and Dr. Collins mentioned exclusions from
seminars, lectures or teaching. I'm not clear how it’s written; does that mean
that it covers all seminars, you know, teaching and that kind of thing that
money that comes from a private company or is it - what - can you explain what
exactly that applies to?

And
how do you know if for instance you have a case where you’re giving a lecture
at a university and it’s funded, you know, that event is funded by a private
company? I mean, how does the person know that I guess? Just gives us a little more detail here on what this does.

Sally Rockey:We had two
areas we excluded from seminars, lectures and teaching and services on advisory
review panels for government agencies or institutions of higher education. But
we did not exclude when that happens with nonprofits or for-profits or other
types of organizations.

Paul Basken:And how do you know, I mean, if you go - if you are a researcher and
you go to another institution, give an address, and it turns out that that
event was funded by, you know, name a drug company. How do you - are you
responsible for knowing and how does that work?

Sally Rockey:Our assumption
is that the investigator will know that.

Paul Basken:Okay.

John Burklow:All right thanks
Paul.

Paul Basken:Thank you.
Yeah, thanks.

John Burklow:Next question
please.

Coordinator:Our next
question comes from Jocelyn Kaiser of Science Magazine.

Jocelyn Kaiser:Hi it’s Jocelyn,
yeah. So I have a couple questions. So one is just to clarify the definition of
significant financial conflicts of interest particularly the $5000 threshold;
that applies to both what’s reported to the institution and what’s reported to NIH? There’s not any difference there is that
right?

Sally Rockey:Oh so remember
the way that it works is that the significant financial interest is what is
reported to the institution from the investigator. The
institution then reports to us when that significant financial interest
constitutes a financial conflict of interest and that’s reported to us.

That
then will tell us - when they report to us they will tell us the value of that
financial interest that created the financial conflict of interest.

Jocelyn Kaiser:Okay. And,
Sally, you were saying that you decided that going down to $100 would be too
much of a burden. But don't a lot of - or at least some institutions now ask
for everything? I mean, it seems like if they can make it work then why can't -
it must be doable?

Sally Rockey:Right. There
are some institutions that have gone down to that level. In fact some of the -
our - the - but again we’re looking for public comment on this particular area.
And remember in our definition of a significant financial interest that also
includes any equity interest in a non-publicly traded entity.

So
that - and at least for that regard it’s any equity when it’s a non-publicly
traded entity.

Jocelyn Kaiser:Okay.

Sally Rockey:So there is a
zero de minimis for that particular category.

Jocelyn Kaiser:Right. Okay and
just one more. So Meredith asked earlier about why - about the fact that the
public disclosure is for greater than, you know, $250,000 there’s no increment.
Why wouldn't you ask for increments above $250,000 on the public side? I mean,
what difference does it really make?

Sally Rockey:Right. So we
felt that it was a significant amount but again we are asking for public
comments and particularly in this area.

Jocelyn Kaiser:But can you say
why you’re not asking for, you know, specific increments above $250,000 on the
public site but you are on the, you know, the institutional information?

Sally Rockey:Instead of
going into all the detail I think it probably if you see our reasoning it’s all
described in the preamble. You can read our reasoning behind that.

Jocelyn Kaiser:Okay.

John Burklow:Thanks Jocelyn.
Next question please.

Coordinator:Doug Lederman
of Inside Higher Ed.

Doug Lederman:Hi, thanks for
taking my call. I just want to understand if I heard you right the institutions
are only responsible - or the only thing that will be made public are the
financial information related to things that the institutions have determined
to be conflicts.

And is
there - will there be some process by which NIH oversees these sort of institution’s judgments either - or will there be
audits or how will the NIH reassure itself that the institutions are making
appropriate judgments on that in determining what are conflicts?

Sally Rockey:Again, yes, that
reasoning does reside with the institutions in the NPRM. We do have a system of
compliance that we (unintelligible) to assure that the institutions are
following their policies. '

In
addition the additional information that we’re going to receive from the
institutions will have more explanation so we - it will allow NIH to determine
whether or not the institution has made the proper decisions and has met the
letter of our policies.

Doug Lederman:So in other words
the information that you'll be getting directly from the institutions will give
you more context with which to...

Sally Rockey:Right.

Doug Lederman:...sort
of either spot check or...

Sally Rockey:Exactly.

Doug Lederman:For whatever
whether they’re - whether they’re making the right - the appropriate judgments
in terms of what they make public.

Sally Rockey:Right. It will
give us a much more broad look at the particular
nature of that decision that they made.

Doug Lederman:And just the last
thing, I'm sorry, so will there be - will that just be sort of a - through the
sort of normal compliance process? You won't be sort of looking at every
decision but you will be spot checking an appropriate way to think about it?

Gregory Jay:Hello. I
haven't had the benefit of reading the NPRM. But would patents pending or
issues but not licensed yet be considered a conflict that’s manageable or not?

Sally Rockey:Institutions
would determine what that conflict is if there is one.

Gregory Jay:Thank you.

John Burklow:Okay and just
remind everyone that this is a press briefing. So we want to make sure the
reporters get a chance to ask their questions. Thanks. Next call please.

Coordinator:Miss Marshall
of ASBMR.

Earline Marshall:Yes, hello. My
name is Earline Marshall; I'm with the American Society for Bone and Mineral
Research. And a few callers ago the response was that nonprofits were I believe
not in the exception. And I just to get - I just wanted to get that clarified
as to what you were talking about.

Sally Rockey:That’s correct.

Earline Marshall:Can you explain
a little bit more about that?

Sally Rockey:So they’re subject
to - they could become a significant financial interest. So income from
nonprofit organizations could be considered as a significant financial interest
depending on the situation.

Earline Marshall:So just to
follow up, you’re talking about stipends or any type money received from
nonprofits?

Sally Rockey:So the
categories that we have described under significant financial interests would
also apply to nonprofits.

Earline Marshall:Okay, thank you.

John Burklow:All right thank
you very much. Next call please and we hit the - next one or two questions.

Coordinator:We do have a
participant that did not record their name. If you pressed star 1 your line is
open.

John Burklow:Okay so it
sounds like we’re wrapping it up. So this is John Burklow again, Communications
Director at NIH. Thank you very much for calling in today. And again remember
there’s the comment period and if you have any questions - press questions our
phone number is 301-496-5787. Again thank you very much.

Francis Collins:Thanks
everybody.

Sally Rockey:Thank you.

John Burklow:Bye-bye.

Francis Collins:Bye.

Sally Rockey:Bye.

Coordinator:Thank you for
joining today’s conference call. You may disconnect at this time.